Thanks to some positive new data, Roche finally has a chance to differentiate itself in the immuno-oncology market for lung cancer. But it’s unclear whether that opportunity can translate into significant sales.
In a phase 3 study, Roche’s Tecentriq combined with chemo beat out solo chemo at cutting the risk of disease worsening or death in previously untreated patients with the squamous form of the disease. As of now, researchers haven’t seen evidence of a benefit to overall survival, but the trial, dubbed IMpower131, is continuing to collect that data.
The results hand Roche the chance to nab a first-to-market lead in the front-line squamous setting. Squamous NSCLC affects just 25% to 30% of all NSCLC patients, but it’s more complicated, and patients have fewer treatment options than those with non-squamous NSCLC, Jefferies analyst Ian Hilliker wrote in a note to clients. Hilliker predicts $1.1 billion in peak sales for Tecentriq in that set of patients.
As Credit Suisse analysts pointed out in their own research note, though, Tecentriq's lead in squamous NSCLC is “likely to be short-lived,” with Merck close behind with a “near-identical” study of its rival med Keytruda.
Tecentriq’s commercial footing is also “unclear until we know the efficacy by PD-L1 status,” the Credit Suisse analysts noted. If it turns out that patients with high levels of PD-L1 drove IMpower131’s positive result, the Tecentriq-chemo pairing could face bruising competition from Keytruda. The Merck med boasts a monotherapy approval in squamous PD-L1-high patients, and it’s “likely to have a much more acceptable side effect burden,” too, the analysts wrote.
The way they see it, the data may well show that the trial win depends on PD-L1-high patients. The anaylsts pointed to the wording in Roche’s press release, highlighting that “Roche does not refer to efficacy as 'clinically meaningful' or the OS trend as 'encouraging’” as it has in the past.
“We would have expected a much more positive tone from the press release if clear efficacy was seen in PD-L1 low/no patients where no comparisons” with Keytruda monotherapy could be drawn.
Meanwhile, Roche has plenty more data to come in the non-squamous first-line setting, where it’s jockeying with Merck, Bristol-Myers Squibb and AstraZeneca for position. It’ll be up to the Swiss drugmaker to show that its Tecentriq-chemo duo can outperform Merck’s, which already has a first-line approval in the bag. BMS and AZ, for their parts, are testing their PD-1/PD-L1 products in tandem with CTLA4 meds Yervoy and tremelimumab, respectively.